Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT06119750
Eligibility Criteria:
Inclusion Criteria:
* Individuals eligible for inclusion in the study were those who:
1. Were male or female, 18 - 75 years of age, in general good health (confirmed by medical history);
2. If females of childbearing potential, were using an acceptable form of birth control (i.e., oral contraceptive, intra-uterine device \[IUD\], diaphragm, condom, abstinence, bilateral tubal ligation, or are in a monogamous relationship with a partner who had a vasectomy);
3. In the case of females of childbearing potential, had a negative urine pregnancy test (UPT) at Screening (a woman was considered to be of non-childbearing potential if she was postmenopausal for at least 12 months or was surgically sterile \[hysterectomy, bilateral oophorectomy\]);
4. Agreed not to use systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
5. Agreed not to use systemic/topical analgesics such as aspirin (81 mg daily aspirin were allowed at the discretion of the Investigator), Aleve, Motrin, Advil, or Nuprin for 72 hours prior to and during the study (occasional use of acetaminophen was permitted);
6. Were free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, interfered with the study results or increased the risk of adverse events (AEs);
7. Were of any skin type or race providing the skin pigmentation allowed for discernment of erythema;
8. Completed a medical screening procedure; and
9. Read, understood, and signed an informed consent agreement
Exclusion Criteria:
* Had any visible skin disease at the study site which, in the opinion of the investigative personnel, would have interfered with the evaluation; 2. Were receiving systematic or topical drugs or medication which, in the opinion of the investigative personnel, would have interfered with the study results; 3. Had psoriasis and/or active atopic dermatitis/eczema; and/or 4. Had a known sensitivity to cosmetics, skin care products, or topical drugs as related to the material being evaluated. 5. Had a history of allergies or sensitivity to study material being tested. 6. Were pregnant women. 7. Were women who were breast-feeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06119750
Study Brief:
Protocol Section:
NCT06119750